[Federal Register Volume 68, Number 43 (Wednesday, March 5, 2003)]
[Notices]
[Pages 10469-10473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5193]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0047; FRL-7294-5]


Trifloxystrobin; Notice of Filing a Pesticide Petition to 
Establish a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0047, must be 
received on or before April 4, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:

[[Page 10470]]

    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in OPP-2003-0047. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0047. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0047. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2003-0047. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access''

[[Page 10471]]

system. If you send an e-mail comment directly to the docket without 
going through EPA's electronic public docket, EPA's e-mail system 
automatically captures your e-mail address. E-mail addresses that are 
automatically captured by EPA's e-mail system are included as part of 
the comment that is placed in the official public docket, and made 
available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0047.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2003-0047. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: February 21, 2003.
 Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed. The Interregional Research Project No. 4 (IR-4) 
assembled and submitted the petition to EPA in behalf of Bayer 
CropScience, the registrant.

Interregional Research Project Number 4 and Bayer CropScience

PP 3E6522

    EPA has received a pesticide petition (3E6522) from Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, 
North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of 
the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.555 by establishing a 
tolerance for residues of trifloxystrobin in or on the raw agricultural 
commodities (RACs) vegetable, root, except sugar beet, subgroup 1B, 
except radish at 0.1 part per million (ppm) and leafy petiole subgroup 
4B at 2.0 ppm. EPA has determined that the petition contain data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of trifloxystrobin in plants 
(cucumbers, apples, wheat, sugar beets, and peanuts), is well 
understood. Identified metabolic pathways are substantially similar in 
plants and animals (goat, rat, and hen). EPA has determined that 
trifloxystrobin parent and its metabolite CGA-321113 are the residues 
of concern for tolerance setting purposes.
    2. Analytical method. A practical analytical methodology for 
detecting and measuring levels of trifloxystrobin in or on RACs has 
been submitted. The limit of detection (LOD) for each analyte of this 
method is 0.08 nanogram (ng) injected, and the limit of quantitation 
(LOQ) is 0.02 ppm. The method is based on crop specific cleanup 
procedures and determination by gas chromatography (GC) with nitrogen-
phosphorus detection.
    3. Magnitude of residues--i. Vegetable root, except sugar beet, 
subgroup 1B, except radish. Interregional Research Project Number 4 
received a request from Michigan for the use of trifloxystrobin on 
carrots. Interregional Research Project Number 4 performed

[[Page 10472]]

10 field trials to support the requested tolerance of 0.1 ppm.
    ii. Leaf petiole subgroup 4B. Interregional Research Project Number 
4 received a request from Florida, Michigan, Oregon, California, and 
Ohio, for the use of trifloxystrobin on celery. Interregional Research 
Project Number 4 performed nine field trials to support the requested 
tolerance of 2.0 ppm.

B. Toxicological Profile

    1. Acute toxicity. Studies conducted with the technical material of 
trifloxystrobin:
    [sbull] Rat. Acute oral toxicity study with a lethal dose 
(LD)50 >5,000 milligrams/kilogram (mg/kg).
    [sbull] Mouse. Acute oral toxicity study with a LD50 
>5,000 mg/kg.
    [sbull] Rabbit. Acute dermal toxicity study with a LD50 
>2,000 mg/kg.
    [sbull] Rat. Acute dermal toxicity study with a LD50 
>2,000 mg/kg.
    [sbull] Rat. Acute inhalation toxicity study with a lethal 
concentration (LC)50 >4.65 milligrams/liter (mg/L).
    [sbull] Rabbit. Eye irritation study showing slight irritation 
(toxicity category III).
    [sbull] Rabbit. Dermal irritation study showing slight irritation 
(toxicity category IV).
    [sbull] Guinea pig. Dermal sensitization study with the Buehler's 
method showing negative findings.
    [sbull] Guinea pig. Dermal sensitization study with the 
maximization method showing some positive findings.
    2. Genotoxicity. No genotoxicity activity is expected of 
trifloxystrobin under in vivo or physiological conditions. The compound 
has been tested for its potential to induce gene mutation and 
chromosomal changes in five different test systems. The only positive 
finding was seen in the in vitro test system (chinese hamster V79 
cells) as a slight increase in mutant frequency at a very narrow range 
(250 - 278 micrograms/milliliter ([mu]g/ml) of cytologic and 
precipitating concentrations (compound solubility in water was reported 
to be 0.61 [mu]g/ml; precipitate was visually noted in culture medium 
at 150 [mu]g/ml). The chemical was found to be non-mutagenic in the in 
vivo system or all other in vitro systems. Consequently, the limited 
gene mutation activity in the V79 cell line is considered a nonspecific 
effect under non-physiological in vitro conditions and not indicative 
of a real mutagenic hazard.
    3. Reproductive and developmental toxicity. FFDCA section 408 
provides that EPA may apply an additional safety factor for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base. Based on the 
current toxicological data requirements, the data base on 
trifloxystrobin relative to prenatal and postnatal effects for children 
is complete.
    In assessing the potential for additional sensitivity of infants 
and children to residues of trifloxystrobin, data were considered from 
teratogenicity studies in the rat, rabbit, and a 2-generation 
reproduction studies in the rat. The teratogenicity studies are 
designed to evaluate adverse effects on the developing embryo as a 
result of chemical exposure during the period of organogenesis. 
Reproduction studies provide information on effects from chemical 
exposure on the reproductive capability of mating animals and systemic 
and developmental toxicity from in utero exposure.
    In the rat teratology study, reductions in body weight gain and 
food consumption were observed in the dam at >=100 mg/kg. No 
teratogenic effects or any other effects were seen on pregnancy or 
fetal parameters except for the increased incidence of enlarged thymus, 
which is a type of variation, at 1,000 mg/kg. The developmental no 
observed adverse effect level (NOAEL) was 100 mg/kg.
    In the rabbit teratology study, body weight loss and dramatically 
reduced food consumption were observed in the dam at >=250 mg/kg. No 
teratogenic effects or any other effects were seen on pregnancy or 
fetal parameters except for the increase in skeletal anomaly of fused 
sternebrae-3 and -4 at the top dose level of 500 mg/kg. This finding is 
regarded as a marginal effect on skeletal development that could have 
resulted from the 40-65% lower food intake during treatment at this 
dose level. The developmental NOAEL was 250 mg/kg.
    In the 2-generation rat reproduction study, body weight gain and 
food consumption were decreased at >=750 ppm, especially in females 
during lactation. Consequently, the reduced pup weight gain during 
lactation (>=750 ppm) and the slight delay in eye opening (1,500 ppm) 
are judged to be a secondary effect of maternal toxicity. No other 
fetal effects or any reproductive changes were noted. The low 
developmental NOAEL, 50 ppm (5 mg/kg), seen in this study was probably 
due to the lack of intermediate dose levels between 50 and 750 ppm. 
Based on an evaluation of the dose-response relationship for pup weight 
at 750 ppm and 1,500 ppm, the NOAEL should have been nearly ten-fold 
higher if such a dose was available.
    Based on all these teratology and reproduction studies, the lowest 
NOAEL for developmental toxicity is 5 mg/kg while the lowest NOAEL in 
the subchronic and chronic studies is 2.5 mg/kg/day (from the rat 
chronic study). Therefore, no additional sensitivity for infants and 
children to trifloxystrobin is suggested by the data base.
    4. Subchronic toxicity. In subchronic studies, several mortality 
related changes were reported for the top dose in dogs (500 mg/kg) and 
rats (800 mg/kg). At these dose levels, excessive toxicity has resulted 
in body weight loss and mortality with the associated and nonspecific 
changes in several organs (such as atrophy in the thymus, pancreas, 
bone marrow, lymph node, and spleen) which are not considered specific 
target organs for the test compound.
    In the dog, specific effects were limited to hepatocellular 
hypertrophy at >=150 mg/kg and hyperplasia of the epithelium of the 
gall bladder at 500 mg/kg. Target organ effects in the rat were noted 
as hepatocellular hypertrophy (>=200 mg/kg) and the related liver 
weight increase (>=50 mg/kg). In the mouse, target organ effects 
included single cell necrosis (>=300 mg/kg) and hypertrophy (1,050 mg/
kg) in the liver and extramedullary hematopoiesis (>=300 mg/kg) and 
hemosiderosis in the spleen (1,050 mg/kg).
    In general, definitive target organ toxicity, mostly in the liver, 
was seen at high feeding levels of over 100 mg/kg for an extended 
treatment period. At the lowest observed adverse effect level (LOAEL), 
no serious toxicity was observed other than mostly non-specific effects 
including a reduction in body weight and food consumption or liver 
hypertrophy.
    5. Chronic toxicity. The liver appears to be the major primary 
target organ based on the chronic studies conducted in mice, rats, and 
dogs. It was identified as a target organ in both the mouse and the dog 
studies with trifloxystrobin. However, no liver effect was seen in the 
chronic rat study which produced the lowest NOAEL of 2.5 mg/kg based on 
reduced body weight gain and food consumption seen at higher dose 
levels.
    The compound did not cause any treatment-related increase in 
general tumor incidence, any elevated incidence of rare tumors, or 
shortened time to the development of palpable or rapidly lethal tumors 
in the 18-month mouse and the 24-month rat studies. Dosages in both 
studies were sufficient for identifying a cancer risk. In the absence 
of carcinogenicity, a reference dose

[[Page 10473]]

(RfD) approach is appropriate for quantitation of human risks.
    6. Animal metabolism. Trifloxystrobin is moderately absorbed from 
the gastrointestinal tract of rats and is rapidly distributed. 
Subsequent to a single oral dose, the half life of elimination is about 
2 days and excretion is primarily via bile. Trifloxystrobin is 
extensively metabolized by the rat into about 35 metabolites, but the 
primary actions are on the methyl ester (hydrolysis into an acid), the 
methoxyimino group (O-demethylation), and the methyl side chain 
(oxidation to a primary alcohol). Metabolism is dose dependent as it 
was almost complete at low doses but only about 60% complete at high 
doses.
    In the goat, elimination of orally administered trifloxystrobin is 
primarily via the feces. The major residues were the parent compound 
and the acid metabolite (CGA-321113) plus its conjugates. In the hen, 
trifloxystrobin is found as the major compound in tissues and in the 
excreta, but hydroxylation of the trifluormethyl-phenyl moiety and 
other transformations, including methyl ester hydrolysis and 
demethylation of the methoxyimino group, are also seen. In conclusion, 
the major pathways of metabolism in the rat, goat, and hen are the 
same.
    7. Metabolite toxicology. Metabolism of trifloxystrobin has been 
well characterized in plants, soil, and animals. In plants and soil, 
photolytically induced isomerization results in a few minor metabolites 
not seen in the rat; however, most of the applied materials remained as 
parent compound as shown in the apple and cucumber studies. All 
quantitatively major plant and/or soil metabolites were also seen in 
the rat. The toxicity of the major acid metabolite, CGA-321113 (formed 
by hydrolysis of the methyl ester), has been evaluated in cultured rat 
hepatocytes and found to be 20 times less cytologic than the parent 
compound. Additional toxicity studies were conducted for several minor 
metabolites seen uniquely in plants and/or soil. The studies indicate 
that these metabolites, including CGA-357261, CGA-373466, and NOA-
414412, are not mutagenic to bacteria and are of low acute toxicity 
(LD50 >2,000 mg/kg).
    In conclusion, the metabolism and toxicity profiles support the use 
of an analytical enforcement method that accounts for parent 
trifloxystrobin.
    8. Endocrine disruption. CGA-279202 does not belong to a class of 
chemicals known for having adverse effects on the endocrine system. 
Developmental toxicity studies in rats, rabbits, and reproduction study 
in rats, gave no indication that CGA-279202 might have any effects on 
endocrine function related to development and reproduction. The 
subchronic and chronic studies also showed no evidence of a long-term 
effect related to the endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. Assessments were conducted to evaluate 
potential risks due to chronic and acute dietary exposure of the U.S. 
population and selected population subgroups to residues of 
trifloxystrobin. These analyses cover all registered crops plus the 
crops of vegetable, root, except sugar beet, subgoup1B, except radish; 
and the leafy petiole subgroup 4B.
    The dietary exposure evaluation model ((DEEM\TM\) v.7.76 software) 
was used to estimate the chronic and acute dietary exposure. This 
software uses the food consumption data from the United States 
Department of Agriculture (USDA) Continuing Surveys of Food Intake by 
Individuals CSFII 1994-1998.
    EPA established an acute population adjusted dose (aPAD) of 2.5 
milligrams/kilogram/day (mg/kg/day) for acute dietary risk assessments 
based on a NOAEL of 250 milligrams/kilogram of body weight/day from a 
rabbit developmental toxicity study and an uncertainty factor (UF) of 
100. For chronic dietary analyses, EPA established a chronic population 
adjusted dose (cPAD) of 0.038 based on a NOAEL of 3.8 from a rat 
reproductive toxicity study and UF of 100.
    Bayer CropScience believes that results from the acute and chronic 
dietary exposure analyses described below demonstrate a reasonable 
certainty that no harm to the overall U.S. population or any population 
subgroup will result from the use of trifloxystrobin on currently 
registered uses plus the pending uses on vegetable root crops, except 
sugar beets, subgoup1B, except radish; and the leafy petiole subgroup 
4B.
    i. Food. Acute and chronic dietary exposure assessments were 
performed using tolerance values for all crops and assuming 100% crop 
treated. Acute exposure, expressed at the 95\th\ percentile of 
exposure, was 0.59% of the aPAD for females 13 to 50 years old (only 
population subgroup of concern). The chronic exposure was 17.3% cPAD 
for the total U.S. population and 51.5% cPAD for the most sensitive 
population, children 1 to 6 years old.
    ii. Drinking water. Using DEEM software, acute and chronic drinking 
water levels of concern (DWLOC) were calculated. The acute DWLOC was 
74,560 and the chronic DWLOC was 1,100 for the total U.S. population 
and 184 for the most sensitive population subgroup, children 1 to 6 
years old. These values are above the estimated concentrations of 
trifloxystrobin and its metabolites in drinking water as published in 
the Federal Register of May 22, 2002, (67 FR 35915-35924) (FRL-7178-6). 
Therefore, Bayer CropScience believe that there is reasonable certainty 
that exposure from trifloxystrobin will not result in harm to the adult 
U.S. population or infants and children.
    2. Non-dietary exposure. As published in the Federal Register of 
May 22, 2002, (67 FR 35915-35924) (FRL-7178-6), EPA calculated post 
application exposure estimates and risk estimates for adults and 
children resulting from the use of trifloxystrobin on turf and 
recreational use sites.
    The margin of exposure (MOE) that resulted were above 100 and all 
risks were considered below EPA's level of concern (LOC).

D. Cumulative Effects

    EPA has determined that unlike other pesticides for which EPA has 
followed a cumulative risk approach based on a common mechanism of 
toxicity, trifloxystrobin does not appear to produce a toxic metabolite 
produced by other substances. Therefore, EPA has not assumed, as 
published in the Federal Register of May 22, 2002, (67 FR 35915-35924) 
(FRL-7178-6), that trifloxystrobin has a common mechanism of toxicity 
with other substances.

E. Safety Determination

    1. U.S. population. Based on the information supplied under 
aggregate exposure described above, Bayer CropScience believe that 
there is reasonable certainty that exposure from trifloxystrobin will 
not result in harm to the adult U.S. population.
    2. Infants and children. Based on the information supplied under 
aggregate exposure described above, Bayer CropScience believes that 
there is reasonable certainty that exposure from trifloxystrobin will 
not result in harm to infants and children.

F. International Tolerances

    There are no codex, Canadian, or Mexican maximum residue limits 
(MRLs) established for trifloxystrobin.
[FR Doc. 03-5193 Filed 3-4-03; 8:45 am]
BILLING CODE 6560-50-S